Intraventricular hydrocephalus drainage device

Abstract

The present application relates to a device for transferring cerebrospinal fluid in the ventricle to the body cavity of other parts of the human body, and specifically discloses a device for draining water in the ventricle, which comprises a base for being attached to a bone window of a skull, a flow collection cavity arranged on the base, a liquid outlet connector in communication with the flow collection cavity, and a flow guide hose connected to the liquid outlet connector; a tip axially away from the base; a drainage main component for guiding cerebrospinal fluid in the ventricle to the flow collection cavity; the drainage main component comprises a plurality of micro-catheters; the proximal end and the distal end of each micro-catheter are respectively attached to the base and the tip, and the micro-central hole of each micro-catheter is in communication with the flow collection cavity at the proximal end; all the micro-catheters are arranged in multiple circles in the circumferential and radial directions; the micro-catheter wall of each micro-catheter is provided with a micro-drainage structure penetrating the micro-central hole, and the micro-drainage structure is arranged in the circumferential and axial directions of the micro-catheter wall to allow cerebrospinal fluid to enter the micro-central hole through the micro-catheter wall.

Description

TECHNICAL FIELD

[0001] The present application relates to an apparatus for transferring body fluid from a human body, and more particularly to a device for draining hydrocephalus. BACKGROUND

[0002] Hydrocephalus is a typical nervous system disease caused by excessive accumulation of cerebrospinal fluid in the brain ventricle. The direct consequence of hydrocephalus is the increase of pressure in the brain ventricle, i.e. the so-called intracranial pressure, which causes the compression of brain tissue. Hydrocephalus can be caused by various reasons, such as intracranial brain tissue injury caused by mechanical impact, brain tissue diseases, such as cerebrospinal fluid metabolism abnormalities, cerebral hemorrhage, cerebral infarction, encephalitis, etc. No matter what the cause of hydrocephalus is, the primary and urgent medical treatment is to lead the excess cerebrospinal fluid out of the brain ventricle to reduce the pressure in the brain ventricle to a reasonable level (at least to a level that does not cause serious consequences to the brain tissue).

[0003] In the prior art, a shunt for leading cerebrospinal fluid from the brain ventricle of a patient to a body cavity (such as the abdominal cavity) of the patient and a shunt system equipped with the shunt have been developed. The typical shunt system includes a tubular shunt component for implanting into the brain ventricle through the skull, a flow guide hose for conveying the cerebrospinal fluid led out of the shunt component to the body cavity, and a flow control valve arranged on the tail (proximal end) of the shunt component or the flow guide hose for controlling the flow of the cerebrospinal fluid led out and thereby avoiding excessive drainage. The typical drainage structure of the shunt component includes a central drainage lumen arranged in the shunt component and a plurality of wall holes opened on the wall of the shunt component. The cerebrospinal fluid enters the drainage lumen through the wall holes and flows along the drainage lumen to the proximal end of the shunt component and then flows into the flow guide hose. The aperture of the wall hole cannot be too large. By requiring to be configured as a micro-hole, on the one hand, larger wall holes will allow some substances (such as protein particles, fragments, blood clot particles) in the cerebrospinal fluid with larger particle sizes to flow to the flow guide hose and the control valve, which may block the flow guide hose and the control valve. On the other hand, larger wall holes will allow larger areas of brain tissue (such as the pia mater around the shunt component) to invade. When the shunt component is taken out of the brain ventricle, the shear effect of the edge of the wall hole on the invaded part of the brain tissue may cause damage to the brain tissue.

[0004] Although the probability of the drainage hose and the control valve being blocked can be significantly reduced and the shear injury to the brain tissue can be avoided by configuring the wall holes on the drainage component as micro-holes, configuring the wall holes as micro-holes has the disadvantage of being easily blocked, and the wall holes are blocked in various ways, for example, the pia mater around the drainage component can invade the wall holes to block the wall holes, for another example, protein fragments can cover the outer circumferential surface of the drainage component due to the throttling pressure difference to block the wall holes from the outer end of the wall holes, for another example, protein particles or blood clot particles can eventually block the wall holes directly or by gathering at the wall holes. If the proportion of the blocked wall holes on the drainage component reaches a certain level, the drainage component will lose the drainage function (the probability of the drainage component losing the drainage function is not low, especially after long-term use of the drainage component), and the intracerebral pressure cannot be reduced to a reasonable level, which is the most serious complication that can occur after the shunt surgery.

[0005] To reduce the probability of the wall holes on the drainage component being blocked, one method developed in the prior art is to arrange a disturbance component (such as a disturbance rod) in the drainage cavity of the drainage component, and attach a wire bundle (such as a brush) for penetrating the wall holes on the disturbance component, and drive the disturbance component to move to drive the wire bundle to disturb the wall holes to prevent the wall holes from being blocked. This method has a certain effect on preventing the wall holes from being blocked. However, this method has the following defects: 1, it is necessary to configure an electric drive component (such as an ultrasonic drive module) for electrically driving the disturbance component on the drainage component, and a power supply for providing electric energy for the electric drive module, which leads to the complexity of the structure of the drainage component; 2, if the disturbance of the wire bundle touches the brain tissue, it can cause damage to the brain tissue; 3, if the wire bundle is limited to extend from the outer end of the wall hole to reduce the probability of touching the brain tissue, the disturbance effect of the wire bundle is difficult to prevent protein fragments from blocking the wall holes; 4, driving the wire bundle to disturb in the wall hole has poor effect on preventing the pia mater from blocking the wall hole, and the disturbance effect can induce the pia mater to grow towards the wall hole. SUMMARY

[0006] In view of the above technical problems existing in the prior art, the present application provides an intracerebral water drainage device.

[0007] To solve the above technical problems, the technical scheme adopted by the present application is:

[0008] An intracerebral water drainage device, comprising:

[0009] a base for being attached at a bone window of a skull, the base being configured with a flow collection cavity and a liquid outlet connector in communication with the flow collection cavity, and a drainage hose being connected to the liquid outlet connector;

[0010] a tip axially away from the base;

[0011] A drainage main component for guiding cerebrospinal fluid in a cerebral ventricle to a collecting chamber; wherein:

[0012] The drainage main component comprises a plurality of micro-catheters; a proximal end and a distal end of each micro-catheter are attached to a base and a tip respectively, and a micro-central hole of each micro-catheter communicates with the collecting chamber at the proximal end; all micro-catheters are arranged in multiple circles in the circumferential and radial directions;

[0013] A micro-drainage structure is configured on the tube wall of each micro-catheter and penetrates the micro-central hole, and the micro-drainage structure is arranged in the circumferential and axial directions of the tube wall of the micro-catheter to allow cerebrospinal fluid to enter the micro-central hole through the tube wall of the micro-catheter.

[0014] Preferably, the micro-drainage structure comprises a plurality of linear slit holes; the plurality of linear slit holes are arranged on the tube wall of the micro-catheter in the circumferential and axial directions; wherein:

[0015] Each linear slit hole extends in the axial direction of the micro-catheter, and the slit width of each linear slit hole increases in the direction from the distal end to the proximal end of the micro-catheter, and the maximum slit width of the linear slit hole is smaller than the diameter of the micro-central hole.

[0016] Preferably, the micro-drainage structure is a helical slit extending on the micro-catheter, and the slit width of the helical slit is smaller than the diameter of the micro-central hole.

[0017] Preferably, the drainage main component further comprises a redundant catheter, and the redundant catheter is located in a central region of a columnar space enveloped by the plurality of micro-catheters.

[0018] The redundant catheter defines a central cavity, a proximal end and a distal end of the redundant catheter are attached to the base and the tip respectively, and the central cavity communicates with the collecting chamber at the proximal end; a redundant drainage structure is configured on the tube wall of the redundant catheter and penetrates the central cavity, and the redundant drainage structure can allow cerebrospinal fluid to enter the central cavity so that the redundant catheter can guide the cerebrospinal fluid to the collecting chamber; wherein:

[0019] The drainage timing of the redundant catheter is configured to allow cerebrospinal fluid to enter the collecting chamber through the redundant drainage structure and the central cavity when the pressure in the cerebral ventricle is greater than a set pressure.

[0020] Preferably, the redundant drainage structure comprises a plurality of drainage windows configured on the tube wall of the redundant catheter, and the plurality of drainage windows are arranged in the circumferential and axial directions; wherein:

[0021] The inner hole wall of the redundant conduit is provided with a valve piece corresponding to each drainage window, the valve piece opens the drainage window by elastic deformation forced by pressure in response to the pressure of cerebrospinal fluid rising to be greater than the set pressure, and the valve piece closes the drainage window by elastic reset.

[0022] Preferably, a mesh spacer sleeve is arranged between the redundant conduit and the micro conduit of the inner ring;

[0023] The outer peripheral surface of the redundant conduit is provided with a plurality of rib strips arranged in an axial direction, each rib strip has a circumferentially arranged and axially penetrating groove; the rib strip supports the mesh spacer sleeve away from the outer peripheral surface of the redundant conduit.

[0024] Preferably, the redundant drainage structure comprises a plurality of micro holes arranged on the wall of the redundant conduit; wherein:

[0025] A check valve component is installed at the junction of the confluence cavity of the base and the central cavity of the redundant conduit, the check valve component allows the cerebrospinal fluid to flow from the central cavity to the confluence cavity and restricts the reverse flow, and the check valve component has an opening pressure that allows the cerebrospinal fluid to flow from the central cavity to the confluence cavity.

[0026] Preferably, a check valve component is installed at the junction of the confluence cavity of the base and the central hole of the redundant conduit, the check valve component allows the cerebrospinal fluid to flow from the central cavity to the confluence cavity and restricts the reverse flow.

[0027] Preferably, the area of the top of the base opposite to the confluence cavity is provided with a transparent observation window.

[0028] Preferably, a liquid inlet connector is further arranged on the base, the liquid inlet connector communicates with the confluence cavity, the liquid inlet connector and the liquid outlet connector both extend radially and are arranged in parallel.

[0029] Preferably, the linear slit hole on the micro conduit is cut by a micro cutter or is laser engraved.

[0030] Preferably, the spiral slit on the micro conduit is wound by a strip on a core needle with a spiral convex rib and is formed by heat molding.

[0031] Compared with the prior art, the beneficial effects of the intracerebral hydrocephalus drainage device disclosed by the application are:

[0032] 1、The present application utilizes the micro drainage structure arranged on the wall and the multiple micro conduits arranged in multiple rings to drain cerebrospinal fluid, thereby improving the drainage effect of cerebrospinal fluid in terms of increasing the total flow cross section and preventing blockage.

[0033] 2、The linear slit hole or spiral slit on the pipe wall covered with micro catheter is used as micro drainage structure, and the drainage effect of cerebrospinal fluid is further improved from the aspect of preventing blockage.

[0034] 3、The present application adds redundant catheter and its accessories, so that the drainage function can be played when the micro catheter drainage fails and approaches failure, thereby providing the drainage device with redundant drainage function.

[0035] 4、The other advantages of the present application are directly or implicitly described in the specific embodiments of the specification.

[0036] The summary of various implementations or examples of the technology described in the present application is not a comprehensive disclosure of the full scope or all features of the disclosed technology. BRIEF DESCRIPTION OF DRAWINGS

[0037] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, various embodiments of the present application and are not intended to limit the present application in any way. The same or similar reference numerals in different drawings can represent the same or similar functionality. Such embodiments of the inventive subject matter can be employed apart from one another, as well as in combination with each other.

[0038] Figure 1 The state of the drainage device provided by the embodiments of the present application implanted in the brain ventricle of a patient.

[0039] Figure 2 The perspective structural schematic diagram of the drainage device provided by the embodiments of the present application.

[0040] Figure 3 The perspective structural schematic diagram of the drainage device provided by the embodiments of the present application (only part of the micro catheter is shown).

[0041] Figure 4 The perspective structural schematic diagram of the micro catheter of the first micro drainage structure.

[0042] Figure 5 The structural view of the drainage device provided by the embodiments of the present application (the redundant catheter is in a state of not participating in drainage).

[0043] Figure 6 The structural view of the drainage device provided by the embodiments of the present application (the redundant catheter is in a state of participating in drainage).

[0044] Figure 7Schematic diagram of attaching valve piece in the process of making the first kind of redundant catheter.

[0045] Figure 8 Schematic diagram of attaching rib in the process of making the first kind of redundant catheter.

[0046] Figure 9 Schematic diagram of the drainage device with the second kind of micro-drainage structure and the micro-catheter of the second kind of structure (only part of the micro-catheter is shown).

[0047] Figure 10 Schematic diagram of the micro-catheter of the second kind of micro-drainage structure.

[0048] 10-drainage main part; 11-micro-catheter; 111-micro central hole; 112-linear slit hole; 113-spiral slit; 12-redundant catheter; 121-central cavity; 122-drainage window; 1221-window; 1222-connecting rib; 123-rib; 1231-groove; 124-micro hole; 13-separation sleeve; 20-base; 21-proximal end socket; 22-proximal end central socket; 23-converging cavity; 241-outlet connector; 242-inlet connector; 25-port; 26-visual window; 30-end head; 31-distal end socket; 32-distal end central socket; 40-valve piece; 41-elastic strip; 50-check valve; 51-circular plate; 511-valve port; 52-circular silica gel piece; 60-check valve; 70-retaining part; 71-mounting hole; 72-through hole; 100-drainage device; 200-drainage hose; 300-ventricle; 301-skull; 400-thin plate. DETAILED DESCRIPTION

[0049] Unless otherwise defined, technical terms or scientific terms used in the present application shall have the ordinary meaning commonly understood by one of ordinary skill in the art to which the present application pertains. The words "first", "second", and similar words of comparison, do not connote any priority, or importance, but are used merely to distinguish a different single element from another. The words "comprise", "comprising", "include", "including" and "contains", "containing", or the like are intended to be inclusive, in that they mean the process, method, article, or apparatus that comprises, includes, or contains those elements in non-exclusive sense, such that additional elements can also be present. The words "connected", "coupled", or the like are not limited to direct or physical connections, but can include an electrical connection, whether direct or indirect.

[0050] In order to keep the following description of the embodiments of the present application clear and concise, the present application omits the detailed description of known functions and known components.

[0051] As shown in Figure 1 The embodiment of the present application discloses a device for draining excess cerebrospinal fluid from the ventricle of a patient's brain, which is implanted into the ventricle of the patient's brain through a bone window of the skull of the patient for draining the excess cerebrospinal fluid from the ventricle of the patient's brain, and the drained cerebrospinal fluid is transported to a body cavity (e.g., the abdominal cavity) of the patient through a drainage hose, and a control valve installed on the drainage hose is used to control the flow of the cerebrospinal fluid to avoid over-drainage.

[0052] As shown in Figure 2 The overall shape of the device for draining excess cerebrospinal fluid from the ventricle of a patient's brain is substantially cylindrical, so the device has two ends in the axial direction. After the device is implanted, one end of the device extends into the ventricle of the patient's brain through a bone window of the skull of the patient, and the other end of the device is exposed outside the skull of the patient. The end of the device used to extend into the ventricle of the patient's brain can be referred to as the distal end, and the end of the device used to be exposed outside the skull of the patient can be referred to as the proximal end.

[0053] As shown in Figures 2 to 10 The device for draining excess cerebrospinal fluid from the ventricle of a patient's brain includes a base 20 at the proximal end, a tip 30 at the distal end, and a drainage main body component 10 between the tip 30 and the base 20. After the device is implanted into the ventricle of the patient's brain, the drainage main body component 10 is substantially located in the ventricle of the patient's brain.

[0054] The base 20 is attached to the skull 301 by a retaining component 70. Specifically, the retaining component 70 has a plate-like structure, and the retaining component 70 has a mounting hole 71 in the central region and a plurality of through holes 72 arranged circumferentially at the edge. Before the device for draining excess cerebrospinal fluid from the ventricle of a patient's brain is implanted into the ventricle of the patient's brain, a bone window is first drilled in a suitable region of the skull 301, and then the mounting hole 71 of the retaining component 70 is aligned with the bone window, and a bone screw is used to pass through the through holes 72 at the edge of the retaining component 70 and is screwed into the skull 301 to fix the retaining component 70 to the skull 301. When the device for draining excess cerebrospinal fluid from the ventricle of a patient's brain is implanted into the ventricle of the patient's brain, the distal end of the device extends into the ventricle of the patient's brain from above the retaining component 70 through the mounting hole 71 and the bone window until the base 20 is embedded in the mounting hole 71. At this time, the retaining component 70 is positioned relative to the device by the assembly fit of the mounting hole 71 and the base 20 to avoid axial, radial movement and shaking of the device. The mounting hole 71 and the base 20 can be positioned relative to the device by assembly fit including but not limited to the following: a downward step surface is configured on the outer peripheral surface of the base 20, a flat stop surface is configured at the end of the mounting hole 71, and a screw clamping structure is configured on the outer peripheral surface of the base 20 and the wall hole of the mounting hole 71. The base 20 is clamped with the retaining component 70 by screwing the base 20 at a small angle, and the step surface abuts against the stop surface.

[0055] AsFigure 3 and Figure 9 As shown in FIG. 1, the sink cavity 23 and the liquid outlet connector 241 are arranged on the base 20, the drainage hose 200 is connected to the liquid outlet connector 241 for finally delivering the cerebrospinal fluid to the body cavity of other parts, specifically, a circular sink is opened from the top of the base 20 (or the proximal end of the base 20) to the bottom of the base 20 (or the distal end of the base 20), a cover plate is arranged on the top of the base 20 to cover the sink, thereby defining the sink cavity 23; the liquid outlet connector 241 extends radially from the side of the base 20, and the drainage hose 200 is attached to the liquid outlet connector 241 transversely, so as to conform to the direction of the drainage hose 200 to avoid being accidentally touched.

[0056] The lower end (or the distal end) of the tip 30 is configured as a spherical surface, which can greatly reduce the damage to the brain tissue caused by the device implantation process during the implantation of the device into the brain ventricle 300. Preferably, the tip 30 is configured as a hemispherical structure, and the upper end (or the proximal end) of the tip 30 is a flat circular surface.

[0057] The drainage main component 10 includes a plurality of micro-catheters 11 with micro-central holes 111. The proximal end and the distal end of each micro-catheter 11 are respectively attached to the base 20 and the tip 30, and the micro-central hole 111 of the micro-catheter 11 is in communication with the sink cavity 23 of the base 20 at the proximal end, while the micro-central hole 111 is blocked at the distal end; all the micro-catheters 11 are arranged in both circumferential and radial directions, thereby forming multiple rings of micro-catheters 11. Specifically, a plurality of proximal end insertion holes 21 corresponding to the micro-catheters 11 are opened through the bottom of the base 20, the upper end of the tip 30 is provided with a plurality of distal end insertion holes 31 corresponding to the micro-catheters 11, the distal end of the micro-catheter 11 is inserted into the distal end insertion hole 31 on the tip 30, the proximal end of the micro-catheter 11 is inserted into the proximal end insertion hole 21 on the base 20, and the proximal end and the distal end of the micro-catheter 11 are fixed by adhesive of biocompatible material.

[0058] The micro-drainage structure is through the micro-central hole 111, and the micro-drainage structure is arranged along the circumference and the axial direction of the tube wall of the micro-catheter 11 so that there is a micro-drainage structure in each direction in the circumferential direction and each position in the axial direction of the tube wall of the distal end section. Since the micro-drainage structure is through the micro-central hole 111, under the action of the cerebrospinal fluid pressure (i.e. the pressure in the brain ventricle 300), the cerebrospinal fluid can enter the micro-central hole 111 through the micro-drainage structure on each micro-catheter 11 and flow along the micro-central hole 111 to the proximal end to flow into the confluence chamber 23, and then be transported through the drainage hose 200 to flow into the body cavity of other parts. The micro-drainage structure can be a circular or circular-like (such as an oval, an ellipse, a polygon) micro-hole with a high arrangement density, or a plurality of linear slit-like holes 112 or spiral slits 113 provided by the application, which will be described below.

[0059] The advantages of the above-mentioned drainage main component 10 for draining cerebrospinal fluid by arranging the micro-catheter 11 in multiple turns are as follows.

[0060] 1. The plurality of micro-catheters 11 arranged in multiple turns can obtain a larger area in contact with the cerebrospinal fluid than a general catheter with a size substantially equal to the size of the columnar surface enveloped by the micro-catheter 11 (the outermost micro-catheter 11), so that the sum of the flow cross sections of the micro-drainage structures of all micro-catheters 11 can be greater than the sum of the flow cross sections of all wall holes on the general catheter by reasonably configuring the structure of the micro-drainage structure (such as a circular hole or a circular-like hole) and increasing the density of the micro-drainage structure as much as possible. In this way, even if the proportion of the micro-drainage structures on the micro-catheter 11 that are blocked is greater than the proportion of the wall holes on the general catheter that are blocked, the drainage effect of all micro-catheters 11 on the cerebrospinal fluid is still better than that of the general catheter.

[0061] 2. It has an advantage in preventing protein fragments from being blocked. Specifically, since the micro-catheter 11 has a much smaller outer diameter than the general catheter, for smaller protein fragments, it is more difficult for them to stably adhere to the columnar surface of the micro-catheter 11 than the general catheter. For larger protein fragments, it is difficult for them to completely adhere to the columnar surface of the general catheter, the area of the covered region of the micro-catheter 11 is smaller, and the flow cross section of the micro-drainage structure that can be blocked is smaller, while the larger protein fragments can cover the entire columnar surface of the general catheter, so the flow cross section of the micro-hole on the general catheter that can be blocked is larger.

[0062] 3. It has advantages in preventing choroid plexus blockage. Specifically, the microcatheters 11 are arranged in multiple rings, and the choroid plexus is blocked by the outermost ring of microcatheters 11, making it difficult for it to reach the inner ring of microcatheters 11. Therefore, the micro-drainage structures of the inner ring of microcatheters 11 are less likely to be blocked by the choroid plexus. In addition, although the choroid plexus can block the micro-drainage structures located in the radially outer region (or basically in the radially outer region) on the outermost ring of microcatheters 11, the micro-drainage structures in the radially inner region are less likely to be blocked.

[0063] The present invention provides two microdrainage structures configured on the wall of the microcatheter 11.

[0064] The first type of micro-drainage structure.

[0065] like Figures 3 to 5 As shown, the microdrainage structure includes a plurality of linear slit-like holes 112 disposed on the wall of the microcatheter 11. These linear slit-like holes 112 are arranged both circumferentially and axially such that they exist at various positions in both the circumferential and axial directions of the wall of the microcatheter 11. Each linear slit-like hole 112 extends axially along the microcatheter 11 such that its extension direction aligns with the flow direction of cerebrospinal fluid within the microcentral aperture 111 of the microcatheter 11. Furthermore, the width of the linear slit-like hole 112 is increased from distal to proximal in the microcatheter 11; that is, the width of the proximal side of the linear slit-like hole 112 is greater than that of the distal side. The maximum width of the linear slit-like hole 112 is smaller than the aperture of the microcentral aperture 111; that is, the width of the proximal side of the linear slit-like hole 112 is smaller than the aperture of the microcentral aperture 111.

[0066] Using numerous linear slit-like holes 112 as a micro-drainage structure has the following advantages in preventing blockage:

[0067] 1. Linear slit-shaped pores with a larger aspect ratio 112 are more effective at inhibiting blockage caused by the aggregation of protein microparticles compared to round or quasi-round pores.

[0068] 2. By extending the linear slit-like opening 112 along the direction of cerebrospinal fluid flow within the micro-central opening 111, and continuously increasing the slit width along the flow direction, protein particles initially intercepted by the linear slit-like opening 112 as cerebrospinal fluid passes through it can be guided by the opening 112 towards the proximal end and may eventually enter the micro-central opening 111 through a wider section of the opening, thus reducing the probability of blockage to some extent. Furthermore, even if protein particles are ultimately intercepted at a certain location within the linear slit-like opening 112, other locations within the opening 112 still allow cerebrospinal fluid to pass through. Additionally, even if protein particles are ultimately intercepted at a certain location within the linear slit-like opening 112, because the opening 112 is axially open, the stability of the protein particles at that location is relatively poor.

[0069] The main body of the microcatheter 11 with the above-described structure can be made of a biocompatible polymer material (e.g., medical polyurethane) through an extrusion process. The linear slit-like holes 112 on the wall of the microcatheter 11 can be formed by cutting the wall with a microblade or by laser engraving the wall with a laser engraving machine. Before cutting the wall with a microblade or engraving the wall with a laser engraving machine, a metal core needle (if cutting with a blade, the metal core needle needs to be equipped with a notch structure corresponding to the linear slit-like holes 112) needs to be inserted through the microcatheter 11 to provide support and prevent the laser from penetrating the microcatheter 11.

[0070] The second type of micro-drainage structure.

[0071] like Figure 9 and Figure 10 As shown, the drainage structure is a spirally extending spiral slit 113 formed on the microcatheter 11, the width of which is smaller than the diameter of the micro-central aperture 111. The area of ​​the flow passage section defined by the spiral slit 113 per unit axial dimension can be increased by reducing the pitch of the spiral slit 113.

[0072] The second micro-drainage structure has similar advantages to the first one, namely, it can effectively avoid being blocked by protein particles. Compared to the first micro-drainage structure, this micro-drainage structure, due to its continuous and longer slits, is superior in disrupting the stability of protein particles intercepted by the slit structure.

[0073] The aforementioned microcatheter 11 can also be made of a biocompatible polymer material. This invention provides two fabrication processes.

[0074] The first manufacturing process is similar to the manufacturing process of the first microcatheter 11, that is, the main body of the microcatheter 11 is made by extrusion, and then the spiral slit 113 is cut out by microblading or engraved by laser engraving machine.

[0075] The second manufacturing process is as follows: First, numerous strips are cut from a sheet-like raw material. Under heating conditions, the strips are wound around the mandrel along the direction of the spiral ribs on the mandrel. Then, they are cooled and shaped to obtain a microcatheter 11 with a spiral slit 113. The width of the spiral ribs determines the width of the spiral slit 113.

[0076] In some preferred embodiments of the present invention, such as Figure 3 and Figure 9 As shown, the main drainage component 10 also includes a redundant catheter 12, the radial dimension of which is significantly larger than that of the microcatheter 11. The redundant catheter 12 defines a central lumen 121, as... Figure 5 As shown, a redundant catheter 12 is arranged in the central section of the cylindrical space encompassed by all the microcatheters 11. The proximal end of the redundant catheter 12 is inserted into a proximal central insertion hole 22 located in the central region of the base 20 and communicating with the manifold 23, thereby connecting the central cavity 121 and the manifold 23. The distal end of the redundant catheter 12 is sealed and inserted into a distal central insertion hole 32 located in the central region of the end 30. A drainage structure, referred to as a redundant drainage structure, is configured on the wall of the distal section of the redundant catheter 12. This redundant drainage structure penetrates the wall and communicates with the central cavity 121. In this way, cerebrospinal fluid can enter the central cavity 121 through the redundant drainage structure, and then the cerebrospinal fluid can flow along the central cavity 121 towards the proximal channel into the manifold 23. Therefore, the redundant catheter 12 can achieve the drainage of cerebrospinal fluid.

[0077] In this invention, the timing of drainage using the redundant catheter 12 is configured such that when numerous microcatheters 11 fail or nearly fail due to blockage of the microdrainage structure or other reasons (the so-called failure of drainage effect should not be understood as a complete inability to drain, but rather as the ability to drain, but the flow rate of cerebrospinal fluid is reduced to the point where the pressure within the ventricle 300 cannot be reduced to a reasonable or required level), the redundant catheter 12 participates in drainage. In this invention, the failure of the drainage function of the microcatheters 11 is determined based on the pressure within the ventricle 300, thereby determining whether the redundant catheter 12 participates in drainage. Therefore, the specific timing of drainage using the redundant catheter 12 is set as follows: if the pressure within the ventricle 300 is greater than a set pressure, the redundant catheter 12 participates in drainage. The set pressure is usually set based on the normal pressure within the ventricle 300. For adults, the normal pressure within the ventricle 300 is 5-15 mmHg. If the pressure within the ventricle 300 is greater than 20 mmHg, it is usually referred to as intracranial hypertension; therefore, the set pressure can be set to 15-20 mmHg. In this invention, the redundant catheter 12 automatically responds to the pressure of the ventricle 300 and drains in real time.

[0078] The present invention provides two specific structures of redundant catheters 12 and corresponding accessories.

[0079] The first type of redundant conduit 12 has a specific structure.

[0080] like Figure 3 , Figure 5 , Figure 6 As shown, the redundant drainage structure of the redundant conduit 12 includes numerous drainage windows 122 disposed on the wall of the proximal section. The numerous drainage windows 122 are arranged circumferentially and axially, thereby forming multiple rings of drainage windows 122 arranged axially. Each drainage window 122 includes two windows 1221, and there is a connecting rib 1222 between the two windows 1221. A valve plate 40 is provided in the area corresponding to each drainage window 122 on the inner wall of the redundant conduit 12. The valve plate 40 can be obtained by cutting an elastic sheet-like component. The middle part of the valve plate 40 is attached and fixed to the connecting rib 1222, and the two windows 1221 are sealed on both sides of the valve plate 40. By rationally configuring the structure and material of the valve plate 40 (for example, selecting a sheet component with a suitable elastic modulus), the valve plate 40 deforms radially inward when compressed by cerebrospinal fluid outside the redundant conduit 12 at a pressure that rises to a set pressure, thus opening the window 1221. In this way, when the pressure of the cerebrospinal fluid in the ventricle 300 is higher than the set pressure, the cerebrospinal fluid automatically enters the central cavity 121 of the redundant conduit 12 and then enters the manifold 23, thereby achieving automatic drainage. When the pressure of the cerebrospinal fluid in the ventricle 300 is lower than the set pressure, the valve plate 40 closes the window 1221, restricting drainage through the redundant conduit 12.

[0081] In some preferred configurations, a septum 13 is provided between the innermost microcatheter 11 and the redundant catheter 12. The septum 13 has a mesh wall and is used to intercept (or filter) protein debris and larger protein (hemoclotting) particles. The purpose of configuring the septum 13 is that if the size of the window 1221 of the drainage window 122 is configured to be small, it will increase the difficulty of processing and installing the valve plate 40 and the difficulty of controlling the deformation timing of the valve plate 40 in the experiment. Therefore, the size of the window 1221 needs to be configured to be large. However, a large window 1221 will allow protein debris and protein (hemoclotting) particles to enter the central cavity 121, the manifold 23, and the drainage hose 200, which may block the drainage hose 200 and the control valve thereon, especially the control valve. Therefore, by configuring the septum 13, which is made of mesh, to intercept protein debris and larger particles, the probability of the drainage hose 200 and the control valve being blocked can be effectively reduced.

[0082] In some preferred configurations, a rib 123 is arranged on the cylindrical surface of the redundant conduit 12 between every two adjacent drainage windows 122. The rib 123 has circumferentially arranged and axially connected grooves 1231. The rib 123 is used to separate the inner wall of the septum 13 from the cylindrical surface. This facilitates the smooth collection of cerebrospinal fluid around the redundant conduit 12 and its entry into the central cavity 121 through the drainage window 122. The grooves 1231 allow the cerebrospinal fluid to communicate axially.

[0083] The following section will introduce the manufacturing method of this redundant conduit 12.

[0084] like Figure 7 and Figure 8 As shown, the main body of the redundant catheter 12 is formed by rolling a thin strip 400 made of a biocompatible polymer. Before rolling, drainage windows 122 with two windows 1221 and connecting ribs 1222 are cut or engraved in a matrix arrangement on the thin strip 400. Furthermore, before rolling, the valve plate 40 is bonded to the connecting rib 1222 of the drainage window 122 on the inner side of the thin strip 400. Specifically, firstly, a silicone plate (sheet) with spaced elastic strips 41 (the elastic strips 41 are used to provide a certain elastic deformation stiffness for the cut valve plate 40, and the timing of the elastic deformation of the valve plate 40 can be controlled by controlling the material, thickness, width, and arrangement density of the elastic strips 41) is used to cut out valve plates 40 arranged in a matrix and corresponding one-to-one with the drainage windows 122 on the thin strip 400 and connected to each other. Then, the matrix arrangement of valve plates 40 is aligned with the rectangular arrangement of drainage windows 122 and covers them accordingly. The middle part of the valve plate 40 is attached and fixed to the connecting rib 1222 at the drainage window 122 by means of adhesive or other means. After attachment and fixation, the connecting strip connecting the valve plates 40 is cut off. Before rolling, strip-shaped components are bonded at intervals to the outside of the thin strip 400, thereby forming ribs 123 on the outside of the redundant guide tube 12 after rolling.

[0085] The redundant conduit 12 with the above structure has the following advantages:

[0086] The valve plate 40 directly responds to the pressure of the cerebrospinal fluid in the ventricle 300 rising to a set pressure and opens the drainage window 122 to perform drainage.

[0087] The second specific structure is redundant conduit 12.

[0088] like Figure 9As shown, the redundant drainage structure of the redundant catheter 12 consists of circular or near-circular micropores 124 formed on the distal section of the redundant catheter 12 and covering the entire tube wall. A check valve 50 is disposed at the port 25 where the distal end of the redundant catheter 12 meets the bottom of the manifold 23. This check valve 50 allows cerebrospinal fluid (CSF) in the central cavity 121 to flow into the manifold 23 by opening port 25, but restricts the flow of CSF from the manifold 23 to the central cavity 121. The opening pressure of the check valve 50 is limited to the aforementioned set pressure. Thus, when the pressure of the CSF in the ventricle 300 exceeds the set pressure, this pressure is transmitted through the micropores 124 and the central cavity 121 to the check valve 50, causing the check valve 50 to open, thereby allowing CSF to continuously flow into the manifold 23 through the micropores 124 and the central cavity 121.

[0089] It should be noted that when the check valve 50 is closed, since there is no pressure difference between the cerebrospinal fluid in the central cavity 121 and the cerebrospinal fluid outside the redundant catheter 12, the cerebrospinal fluid outside the redundant catheter 12 will not flow toward the micropore 124 nor will it tend to flow toward the micropore 124. Therefore, before the drainage of the microcatheter 11 fails, since the cerebrospinal fluid will basically not flow toward the micropore 124 or tend to flow, the possibility of the micropore 124 being blocked is low. Even if protein particles are aggregated at the micropore 124, the stability of the protein particle aggregation is poor.

[0090] In some preferred configurations, the check valve 50 includes a circular plate 51 with a plurality of circumferentially arranged valve ports 511 installed at port 25 at the bottom of the manifold 23, and a circular silicone sheet 52 disposed on the circular plate 51 and sealing the valve ports 511 (an elastic strip 41 is attached and fixed to the rear side of the circular silicone sheet 52 to provide elastic deformation stiffness). The center of the circular silicone sheet 52 is attached and fixed to the center of the circular plate 51, so that the edge of the circular silicone sheet 52 elastically deforms in response to the pressure of the cerebrospinal fluid in the central cavity 121, thereby opening the valve ports 511, so that the cerebrospinal fluid enters the manifold 23 through the valve ports 511. Preferably, the pressure of the cerebrospinal fluid that causes the circular silicone sheet 52 to elastically deform is set to be less than the pressure of the cerebrospinal fluid that causes the valve plate 40 to elastically deform as described above.

[0091] In some preferred configurations, an inlet connector 242 communicating with the manifold 23 is also provided on the base 20. Preferably, the inlet connector 242 is located on the side of the base 20 and extends radially. The inlet connector 242 and the outlet connector 241 are arranged in parallel. In the device with the first redundant conduit 12, a check valve 60 is also installed at the port 25 where the redundant conduit 12 meets the lower part of the manifold 23. The check valve 60 allows cerebrospinal fluid to flow from the central cavity 121 to the manifold 23 while restricting the flow of cerebrospinal fluid from the manifold 23 to the central cavity 121. The check valve 60 is configured with a very small opening pressure, which is much smaller than the opening pressure of the check valve 60 on the proximal side of the second redundant conduit 12. Preferably, a duckbill-type one-way valve made of silicone is used as the check valve 60. In this way, during drainage, the inlet connector 242 is in a closed state. If it is necessary to administer medication or physiological cleaning solution into the ventricle 300, the outlet connector 241 is closed and the inlet connector 242 is opened. The liquid enters the manifold 23 through the inlet connector 242. The check valves 50 and 60 at the bottom of the manifold 23 restrict the flow of liquid to the central cavity 121, so that the liquid can only flow into the micro-central hole 111 of the microcatheter 11 through the proximal end of the microcatheter 11, and then flow into the ventricle 300 through the micro-drainage structure on the microcatheter 11, thereby achieving the purpose of administering medication and reverse cleaning micro-drainage structure.

[0092] In some preferred configurations, a viewing window 26 is provided at the top of the manifold 23. For example, the viewing window 26 is obtained by making the cover plate sealing the top of the manifold 23 transparent. The significant function of the viewing window 26 is that the opening and closing status of the check valves 50 and 60 can be observed visually. If the check valves 50 and 60 are in the open state, it indicates that the redundant catheter 12 has participated in drainage, which indicates that the microcatheter 11 may have failed or is close to failing in drainage.

[0093] Furthermore, although exemplary embodiments have been described in this invention, their scope includes any and all embodiments based on the invention that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, and such examples will be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered illustrative only, and the true scope and spirit are indicated by the full scope of the following claims and their equivalents.

[0094] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments can be used by those skilled in the art when reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the invention. This should not be construed as an intention that a disclosed feature, which is not claimed, is necessary for any claim. Rather, the subject matter of the invention may be less than all the features of the particular disclosed embodiments. Thus, the following claims are incorporated herein by reference as examples or embodiments, wherein each claim is independently considered as a separate embodiment, and these embodiments are contemplated as being able to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

[0095] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within its spirit and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of the present invention.

Claims

1. An intracerebroventricular hydrocephalus shunt device, characterized in that, The application relates to a ventricular shunt device, comprising: a base for attachment at a bone window of a skull, the base being provided with a collecting cavity and a liquid outlet connector in communication with the collecting cavity, a soft tube being connected to the liquid outlet connector; a tip axially distanced from the base; a shunt body for guiding cerebrospinal fluid from a ventricle to the collecting cavity; wherein: the shunt body comprises a plurality of micro-catheters, each micro-catheter having a proximal end and a distal end attached to the base and the tip respectively, and each micro-catheter having a micro-central hole in communication with the collecting cavity at the proximal end, all micro-catheters being arranged in multiple circumferential and radial rows; each micro-catheter is provided with a micro-drainage structure penetrating the micro-central hole, the micro-drainage structure being arranged along the circumferential and axial direction of the micro-catheter to allow cerebrospinal fluid to enter the micro-central hole through the wall of the micro-catheter; the shunt body further comprises a redundant catheter located in a central region of a columnar space enveloped by the plurality of micro-catheters; the redundant catheter defines a central cavity, the proximal end and the distal end of the redundant catheter are attached to the base and the tip respectively, and the central cavity is in communication with the collecting cavity at the proximal end; the wall of the redundant catheter is provided with a redundant drainage structure penetrating the central cavity, the redundant drainage structure is capable of allowing cerebrospinal fluid to enter the central cavity so that the redundant catheter can guide cerebrospinal fluid to the collecting cavity; wherein: the drainage timing of the redundant catheter is configured to allow cerebrospinal fluid to enter the collecting cavity through the redundant drainage structure and the central cavity when the pressure in the ventricle is greater than a set pressure; the redundant drainage structure comprises a plurality of drainage windows arranged on the wall of the redundant catheter in the circumferential and axial directions; wherein: the inner hole wall of the redundant catheter is provided with a valve piece corresponding to each drainage window, the valve piece is elastically deformed by pressure to open the drainage window when the pressure of cerebrospinal fluid is greater than the set pressure, and the valve piece is elastically reset to close the drainage window; a mesh spacer is arranged between the redundant catheter and the inner row of micro-catheters; the outer circumferential surface of the redundant catheter is provided with a plurality of rib strips arranged in the axial direction, each rib strip has a circumferentially arranged and axially penetrating groove; the rib strips support the mesh spacer away from the outer circumferential surface of the redundant catheter.

2. The intracerebroventricular hydrocephalus shunt according to claim 1, characterized in that the micro-drainage structure comprises a plurality of linear slit holes; a plurality of linear slit holes are arranged on the wall of the micro-catheter in the circumferential and axial directions; wherein: each linear slit hole extends along the axial direction of the micro-catheter, and in the direction from the distal end to the proximal end of the micro-catheter, the slit width of each linear slit hole increases, and the maximum slit width of the linear slit hole is smaller than the diameter of the micro-central hole.

3. The intracerebroventricular hydrocephalus shunt according to claim 1, characterized in that the micro-drainage structure is a spiral slit formed on the micro-catheter, and the slit width of the spiral slit is smaller than the diameter of the micro-central hole.

4. The intracerebroventricular hydrocephalus shunt according to claim 1, characterized in that a check valve component is installed at the junction of the collecting cavity of the base and the central hole of the redundant catheter, the check valve component allows cerebrospinal fluid to flow from the central cavity to the collecting cavity and restricts reverse flow.

5. The intracerebroventricular hydrocephalus shunt according to claim 1, characterized in that the top of the base opposite to the collecting cavity is provided with a transparent observation window.

6. The intracerebroventricular hydrocephalus shunt according to claim 4, characterized in that The base is further provided with a liquid inlet connector in communication with the converging cavity, and the liquid inlet connector and the liquid outlet connector are radially extended and arranged in parallel.

7. The intracerebroventricular hydrocephalus shunt according to claim 2, characterized in that The linear slit-shaped hole on the micro catheter is cut by a micro cutter or is laser engraved.

8. The intracerebroventricular hydrocephalus shunt according to claim 3, characterized in that The spiral slit on the micro catheter is wound by a strip on a core needle with a spiral convex rib and is formed by heat molding.

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